The Recall Desk
HighFDA (Devices)·Z-1855-2013·Announced 2013-08-14

Hospira Recalls Blood Sets Due to Potential Bag Puncture Risk

Hospira is recalling specific blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed adverse events.

Plain-English summary

Hospira Inc. is recalling 288 units of List No. 14211-28 PLUM BLOOD SETS. These medical devices are designed for blood product administration and feature a pre-pierced port, 200 micron filter, and non-DEHP material. The affected lots are 052945H and 211855H.

The recall was initiated because it was discovered that the piercing pin on these specific blood sets has the potential to puncture the outer wall of blood bags during the insertion of the pin. This defect could compromise the integrity of the blood product container.

The affected products were distributed nationwide in the United States, in Puerto Rico, and internationally to Costa Rica. Consumers and healthcare facilities should check their inventory for the specific list number and lot numbers listed above and stop using these products if they match the recall criteria.

The recalled product

Product
List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product
Manufacturer
Hospira Inc.
Category
Medical Device — Blood Administration Sets
Hazard
Affected units
288

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • List Number: 14211-28
  • Lot Numbers: 052945H
  • 211855H

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 9 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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